Catalyst Event
Biogen Inc (BIIB) · Other
From Akros U.S. Tech 100 Index (AUT100)
5/24/2026, 12:00:00 AM
U.S. FDA decision on LEQEMBI IQLIK (subcutaneous) for treatment initiation is scheduled. The FDA granted Priority Review for this supplemental Biologics License Application, with a PDUFA action date of May 24, 2026, which is expected. This event is expected to have a high price impact due to the significant market potential of the new delivery method.
Korean Translation
미국 FDA의 피하주사형 레켐비(LEQEMBI IQLIK) 치료 시작에 대한 결정이 예정됨. FDA는 이 보충 생물학적 제제 허가 신청(sBLA)에 대해 우선 심사를 부여했으며, 전문의약품 허가 신청자 비용 부담법(PDUFA)에 따른 목표일은 2026년 5월 24일로 예상됨. 새로운 투여 방식의 상당한 시장 잠재력으로 인해 높은 주가 영향이 예상됨.
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